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paraiškos dėl leidimo atlikti klinikinį tyrimą dokumentų rinkinyje pateikiami visi dokumentai ir informacija, būtini validacijai ir vertinimui, nurodyti ii skyriuje ir susiję su:
the application dossier for the authorisation of a clinical trial shall contain all the documentation and information necessary for the validation and assessment referred to in chapter ii and relating to: